Indications and uses
For temporary relief of pain & inflammation for temporary relief of pain & inflammation
Vonaflex
- Manufacturer
- Cymbiotics, Inc | Westwood Laboratories, LLC
- Effective date
- 2024-12-13
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:43:37
Label at a glance#
ProductVonaflex
Active ingredientLIDOCAINE
Label structure8 sections
Dosage and administration
Use only as directed. Adults & children 12 years or older: apply evenly to affected area not more than 3-4 x daily. For children under 12 years, consult with doctor for recommendations. The Indications and Directions section was renameded to Dosage and Administration. This was noted as required 34068-7 This change was made on 7/21/2022 as directed. 07/26/22-- As per validation request, changed Directions to come u...
Storage and handling
Store at 20 o - 25 o C (68 o - 77 o F),. Protect from freezing or storing in direct sunlight.
Contacts and useful links#
Websitewww.optimallabortories.com
www.optimallabortories.com
www.optimallabortories.comLabel contents#
Full prescribing information#
Active Ingredient
Lidocaine 4%
Uses
For temporary relief of pain & inflammation
Uses
for temporary relief of pain & inflammation
Directions
Use only as directed. Adults & children 12 years or older: apply evenly to affected area not more than 3-4 x daily. For children under 12 years, consult with doctor for recommendations.
Change in heading as requested after review of draft
The Indications and Directions section was renameded to Dosage and Administration. This was noted as required 34068-7 This change was made on 7/21/2022 as directed.
07/26/22-- As per validation request, changed Directions to come under Dosage and Administration.
WARNINGS SECTION
For External use only.
Do not use:on wounds, raw surfaces or blistered areas, with a heating pad, or if allergic to product ingredients
When using this product:Avoid eye contact; do not use excessive amounts; do not exceed recommended dosage unless directed by doctor; do not bandage applied area.
Stop and ask doctor if:an allergic reaction occurs; condition worsens or does not improve within 7 days.
If pregnant or breast-feeding:consult with doctor before use.
if swallowed, get medical help or contact a Poison Control Center.
Precautions Concerning Children
Keep out of reach of children.
Other Information:
Store at 20 o- 25 oC (68 o- 77 oF),. Protect from freezing or storing in direct sunlight.
INACTIVE INGREDIENT SECTION
Arnica Montanaflower extract, cetearyl alcohol, cetyl ester waxes, cyclopentasiloxane, disodium EDTA, ethoxydiglycol, fragrance, Helianthus annuus(sunflower) oil, Lavandula Angustifolio(lavender) oil, methylparaben, PEG40 hydrogenated caster oil, poly(acrylic acid) 2-propionic acid homopolymer, propylene glycol, propylparaben, tetrahydrocurcumin, tocopherol acetate, triethanolamine, water.
Questions and Comments
(212) 535-1700
Package Label and Principal Display Panel Vonaflex
NDC 36590-6451-03 front & back label
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 36590-6461 | VONAFLEX (LIDOCAINE LOTION) LOTION [CYMBIOTICS, INC] | 5 | Legacy NDC | 20241215_dd30ccaf-d239-9d82-e053-2a95a90a6e84.zip |
Products#
Every source-derived product name is available through these pages.
- Vonaflex
- Lidocaine Lotion
- METHYLPARABEN
- EDETATE DISODIUM
- PROPYLPARABEN
- WATER
- SUNFLOWER OIL
- CARBOMER 940
- LAVENDER OIL
- POLYOXYL 40 HYDROGENATED CASTOR OIL
- PROPYLENE GLYCOL
- DIETHYLENE GLYCOL MONOETHYL ETHER
- CETYL ESTERS WAX
- CETOSTEARYL ALCOHOL
- TETRAHYDRODIFERULOYLMETHANE
- TROLAMINE
- .ALPHA.-TOCOPHEROL ACETATE
- CYCLOMETHICONE 5
- FRAGRANCE LAVENDER ROSE ORC1004596
- ARNICA MONTANA FLOWER WATER
- LIDOCAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 36590-6461 | 36590-6461-1, 36590-6461-2, 36590-6461-3, 36590-6461-4, 36590-6461-5 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 42797949-24f3-3b3b-e063-6394a90a2b06 | dd30ccaf-d239-9d82-e053-2a95a90a6e84 | 2025-10-31 | Warnings | dd30ccaf-d239-9d82-e053-2a95a90a6e84 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.